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RecruitingNCT04638452AUTICOPPUpdated Mar 16, 2026

Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice

An interventional study of Video & movements recording and Questionnaires in Autism Spectrum Disorder, sponsored by Centre Hospitalier Charles Perrens, Bordeaux. Recruiting at 1 site in France. Open to participants aged 6 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Centre Hospitalier Charles Perrens, Bordeaux · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Years to 65 Years
Sex
All
01

Study summary

The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

Read the detailed description

The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

The aim is to analyse in an automated and standardised way video recording during a blood test performed as part of routine follow-up care for people presenting ASD (children and adults), qualitative data (type of emotion) and quantitative (intensity)

  1. Emotional facial reactions
  2. Behavioural reactions (video recording of participants' movements)
  3. Physiological reactions (wireless smart watch worn on the wrist)
  4. Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)
02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • autism spectrum disorders
  • behaviour
  • emotions
  • Physiological reactions
  • Psychological reactions
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 150 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux is the lead sponsor of 19 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All participants :

  • Person over 6 years of age
  • Person who consent to participate in the study
  • Membership of the social security scheme
  • Person who not received analgesic treatment that may interfere with pain perception
  • Person with medical prescription for blood sample

Participants with ASD :

  • Person with ASD diagnosis
  • If applicable, legal authority consent to participate in the study

Exclusion criteria

Exclusion Criteria:

All participants :

  • Person with unstabilized drug therapy
  • Person with acute or chronic pain
  • Person with pathology or receiving a treatment which can have an impact in modification of the pain
  • Person with oculomotor and/or neuro-motor disorders
  • Pregnant or breastfeeding woman
  • Person with deprivation of liberty
  • Person who no consent to participate in the study or no consent to realised video recording

Participants without ASD :

  • Protected adult
  • Person with ASD diagnosis
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Epidemiology

    Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test Passing self and hetero questionnaires of temotion felt and perceived.

    Behavioral: Video & movements recording · Behavioral: Questionnaires

Interventions

  • BehavioralVideo & movements recording

    Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test

  • BehavioralQuestionnaires

    Passing self and hetero questionnaires of emotion felt and perceived.

06

What researchers measure

Primary outcomes

  1. Facial expression during blood sample

    Evaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware.

    Time frame: through study completion, an average of 1 to 6 months

  2. Body movement during blood sample

    Evaluation of body movement during blood sample in people with ASD as compared to healthy people with EMPATICA watch and Face, Legs, Activity, Cry, Consolabilty (FLACC) scale

    Time frame: through study completion, an average of 1 to 6 months

Secondary outcomes

  1. Evaluation of emotion felt by participants during blood sample

    Evaluation of emotion felt by participants (anxiety, stress, pain, apprehension…) during blood sample with implified Scale for Assessing Pain in Dyscommunicatives People with Autism Spectrum Disorders (ESSDA) and Pain Assessment Grid - Intellectual Disability (GEDDI) scales

    Time frame: through study completion, an average of 1 to 6 months

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Charles PERRENS
    Bordeaux, 33076, France
    Recruiting
08

References and documents

Publications

  • Hilton CL, Harper JD, Kueker RH, Lang AR, Abbacchi AM, Todorov A, LaVesser PD. Sensory responsiveness as a predictor of social severity in children with high functioning autism spectrum disorders. J Autism Dev Disord. 2010 Aug;40(8):937-45. doi: 10.1007/s10803-010-0944-8. PubMed 20108030 ↗
  • Hirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bolte S. Premature mortality in autism spectrum disorder. Br J Psychiatry. 2016 Mar;208(3):232-8. doi: 10.1192/bjp.bp.114.160192. Epub 2015 Nov 5. PubMed 26541693 ↗
  • Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219. PubMed 14662579 ↗
  • Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. doi: 10.1017/s001216220400060x. PubMed 15174527 ↗
  • Dubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. doi: 10.1155/2010/749275. French. PubMed 20808970 ↗
  • Allely CS. Pain sensitivity and observer perception of pain in individuals with autistic spectrum disorder. ScientificWorldJournal. 2013 Jun 13;2013:916178. doi: 10.1155/2013/916178. Print 2013. PubMed 23843740 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04638452
Lead sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Responsible party
Sponsor
First posted
Nov 20, 2020
Start date
Feb 8, 2021
Primary completion
Nov 30, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Mar 16, 2026

Study contacts

Anouck AMESTOY, MD
Contact
aamestoy@ch-perrens.fr
0556566719
helen SAVARIEAU
Contact
hsavarieau@ch-perrens.fr
0556563556
Anouck AMESTOY, MD
study director · Physician

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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